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Pancreatic TumorsIMPACTNCT06858631

IMPact of AerobiC Exercise in Addition to Nutritional Treatment on Quality of Life After Pancreatectomy

A study testing Physical Aerobic Exercise in people with Pancreatic Tumors and Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this interventional study is to assess the impact of a 6-month unsupervised aerobic exercise program on the quality of life of patients undergoing partial or total pancreatectomy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Tumors, Diabetes, Malabsorption
What is being tested?
Physical Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteItaly
Study dates
1 Jan 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Male or female patients who have undergone partial or total pancreatectomy
  • Age ≥18 and ≤80 years
  • Ability to understand and complete questionnaires and willingness to participate in periodic assessments
  • No symptoms suggestive of cardiovascular issues (e.g., angina, dyspnea, palpitations, syncope)
  • No evidence of ischemic heart disease, cardiomyopathy, valvular heart disease, myocarditis, autoimmune diseases, infections, or fractures that would contraindicate moderate-intensity aerobic activity

Who cannot join

  • Age >80 or <18 years
  • Cardiovascular, musculoskeletal, rheumatologic, or neurocognitive disorders contraindicating aerobic exercise
  • 10-year cardiovascular risk >20% without cardiological/sports medicine evaluation
  • Diagnosis of unresectable tumor
  • Presence of metastases
  • Pregnancy or breastfeeding
Show all 9Show fewer
  • Ongoing chemotherapy and/or radiotherapy
  • BMI ≥30
  • BMI ≤18.5

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, RM, 00168

Other trials in Italy

About this study

Official title: IMpact of a Program of AerobiC Physical Exercise and Nutritional Therapy, on Quality of Life and Glycometabolic Compensation in Patients Undergoing Pancreatectomy

The goal of this interventional study is to assess the impact of a 6-month unsupervised aerobic exercise program on the quality of life of patients undergoing partial or total pancreatectomy. The main question it aims to answer is:

Does an aerobic exercise program improve physical functioning and overall quality of life in post-pancreatectomy patients?

Eligible participants will be assigned to either an exercise group or a control group. Quality of life will be evaluated using standardized scoring scales, with a focus on physical functioning. Secondary outcomes include changes in metabolic parameters (glycemia, HbA1c, lipid profile), BMI, and overall survival.

Being tested
Physical Aerobic Exercise
Keywords
Pancreatectomy, Quality of Life, Physical Exercise
Medical subject headings
Pancreatic Neoplasms, Diabetes Mellitus, Malabsorption Syndromes, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Aerobic ExerciseBehavioural

    Also called Physical activity

    30-minute net aerobic exercise sessions at moderate intensity (3-5 METS, 60%-70% of maximum heart rate) three times per week. Walking, cycling, or swimming, with the option to alternate activities to enhance adherence to the program. Each session will include 10 minutes of warm-up (gradual increase in intensity); 30 minutes of aerobic exercise and 10 minutes of cool-down (gradual reduction of intensity and optional stretching). Total weekly exercise duration will be 150 minutes

Study groups in NCT06858631
Study groupRoleWhat they receive
Performing Physical ExerciseExperimentalSubjects will perferm 30-minute net aerobic exercise sessions at moderate intensity (3-5 METS, 60%-70% of maximum heart rate) three times per week. Participants may choose from walking, cycling, or swimming, with the option to alternate activities to enhance adherence to the program. Each session will include 10 minutes of warm-up (gradual increase in intensity); 30 minutes of aerobic exercise and 10 minutes of cool-down (gradual reduction of intensity and optional stretching). Total weekly exercise duration will be 150 minutes.
Receives: Behavioral: Physical Aerobic Exercise
ControlNo interventionSubjects will undergo usual nutritional and endocrinological follow up after pancreatectomy. They will not perform any physical aerobic exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in quality of life

    Identify changes in the quality-of-life score from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (v3). The EORTC QLQ-C30 (v3) evaluates health status through nine multi-item scales: Five functional scales (physical, role, cognitive, emotional, social); three symptom scales (fatigue, pain, nausea/vomiting); one global health status scale. Additionally, six single-item scales assess symptoms commonly associated with neoplastic disease and its treatment (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

    Measured: 12 months

Secondary outcomes (3)

  1. Detect changes in physical symptomps with the pancreas-specific PAN26 questionnaire.

    Assess possible changes in physical symptomps with the pancreas-specific PAN26 questionnaire. The PAN26 questionnaire consists of 26 four-level items, producing seven multi-item scale scores (each composed of two to four items) and nine single-item scores.

    Measured: 12 months

  2. Assessing changes in muscle power between subjects ongoing nutritional plan versus subjects ongoing nutritional plan and physical exercise

    The subjects will be using their dominant hand, applies as much grip pressure as possible on the dynamometer. The assistant will record the maximum reading (kg). The subjects will repeat the test 3 times and the highest recorded value will be recorded to assess the subject's performance.

    Measured: 12 months

  3. Detect changes in body mass index during the follow-up.

    At each follow-up visit, height (m) and weight (kg) will be recorded. BMI will then be measured as kg/m².

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858631
Sponsor's protocol ID
6706
Acronym
IMPACT
Status last verified
Jan 2025
First submitted
24 Feb 2025
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Katsourakis A, Vrabas I, Papanikolaou V, Apostolidis S, Chatzis I, Noussios G. The Role of Exercise in the Quality of Life in Patients After Pancreatectomy: A Prospective Randomized Controlled Trial. J Clin Med Res. 2019 Jan;11(1):65-71. doi: 10.14740/jocmr3675. Epub 2018 Dec 3.

    PubMed 30627280

  • Yeo TP, Burrell SA, Sauter PK, Kennedy EP, Lavu H, Leiby BE, Yeo CJ. A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll Surg. 2012 Apr;214(4):463-75; discussion 475-7. doi: 10.1016/j.jamcollsurg.2011.12.017. Epub 2012 Feb 7.

    PubMed 22321518

  • Duijts SF, Faber MM, Oldenburg HS, van Beurden M, Aaronson NK. Effectiveness of behavioral techniques and physical exercise on psychosocial functioning and health-related quality of life in breast cancer patients and survivors--a meta-analysis. Psychooncology. 2011 Feb;20(2):115-26. doi: 10.1002/pon.1728.

    PubMed 20336645

  • Sweegers MG, Altenburg TM, Chinapaw MJ, Kalter J, Verdonck-de Leeuw IM, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, Brug J, Buffart LM. Which exercise prescriptions improve quality of life and physical function in patients with cancer during and following treatment? A systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2018 Apr;52(8):505-513. doi: 10.1136/bjsports-2017-097891. Epub 2017 Sep 27.

    PubMed 28954800

  • Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

    PubMed 31626055

  • Rock CL, Thomson CA, Sullivan KR, Howe CL, Kushi LH, Caan BJ, Neuhouser ML, Bandera EV, Wang Y, Robien K, Basen-Engquist KM, Brown JC, Courneya KS, Crane TE, Garcia DO, Grant BL, Hamilton KK, Hartman SJ, Kenfield SA, Martinez ME, Meyerhardt JA, Nekhlyudov L, Overholser L, Patel AV, Pinto BM, Platek ME, Rees-Punia E, Spees CK, Gapstur SM, McCullough ML. American Cancer Society nutrition and physical activity guideline for cancer survivors. CA Cancer J Clin. 2022 May;72(3):230-262. doi: 10.3322/caac.21719. Epub 2022 Mar 16.

    PubMed 35294043

Questions about this trial

What is this clinical trial studying?

A study testing Physical Aerobic Exercise in people with Pancreatic Tumors and Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06858631, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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